Total Serum Bilirubin Measurements Research Articles

Neonatal Transcutaneous Bilirubin Measurements: An Opportunity to Enhance Laboratory Utilization and Improve Patient Care

By far the most common clinical problem addressed by family practitioners and pediatricians in the first weeks of an infant's life is hyperbilirubinemia. With the exception of the standard metabolic screen, the measurement of a total serum bilirubin (TSB)2 concentration is the most common laboratory test ordered for a newborn infant. That is not surprising because the clinical sign, jaundice, is seen in approximately 80% of infants in a well-baby nursery during the first few days (1). The process of observation, clinical monitoring, and laboratory testing that continues throughout the infant's first week of life has a single objective—to prevent extreme hyperbilirubinemia [a TSB concentration >25–30 mg/dL (>428–513 μmol/L)] and its rare but dreaded consequence, bilirubin encephalopathy. Data from most of the Western world suggest that chronic bilirubin encephalopathy, or kernicterus, is currently occurring at an incidence of approximately 0.5–2 per 100 000 live births (2). Thus, of approximately 4 × 106 infants born annually in the US, perhaps 20–40 will develop kernicterus, a permanently disabling condition characterized by athetoid cerebral palsy, severe sensorineural hearing loss, paralysis of upward gaze, and dental dysplasia. For decades practitioners have relied on the appearance and intensity of jaundice as a means of deciding when to obtain a TSB measurement, but recognizing that estimating TSB by eye is difficult and on occasion grossly misleading (3) has prompted the development of transcutaneous bilirubinometry. The instruments that measure the transcutaneous bilirubin (TcB) concentration operate by transmitting light that penetrates the blanched skin and transilluminates the subcutaneous tissues. The …

Transcutaneous bilirubin measurement: Comparison of Respironics BiliCheck and JM-103 in a normal newborn population

To compare the accuracy of BiliCheck™ (Respironics, Marietta, GA) and Konica-Minolta Air Shield JM-103 (Drager Medical Inc, Telford, PA) to evaluate total serum bilirubin (TSB). Prospective blinded study comparing two diagnostic devices in 630 neonates requiring TSB measurement. Linear regression analysis showed a good correlation between BiliCheck™ and TSB (r=0.8212) as well as between JM-103 and TSB (r=0.8686). BiliCheck shows a tendency to underestimate TSB. The mean difference in TSB-TcB was -1.4 mg/dL for BC (-4.7/+1.8 mg/dL) and 0.3 mg/dL for JM-103 (-2.6/+3.2mg/dL). ROC analysis for TSB≥ 12 mg/dL showed area under the curve for BiliCheck™ significantly lower than those for JM-103 (p<0.0001). JM-103 resulted less time expensive than BiliCheck. In spite of similar diagnostic accuracy JM-103 could be preferred for some practical advantages, but its suitability in performing universal screening for severe hyperbilirubinemia deserves further investigations.

Effect of universal neonatal transcutaneous bilirubin screening on blood draws for bilirubin analysis and phototherapy usage

To determine the effect of universal transcutaneous bilirubin (TcB) screening on total serum bilirubin (TSB) blood draws and phototherapy usage. The subjects were infants ≥ 36 weeks gestation. In period 1, TSB was ordered based on clinical factors. In period 2, all infants underwent predischarge TcB measurement; infants with adjusted TcB values in the high-intermediate or high-risk zones had TSB ordered. Data were extracted through chart review. TSB measurements per 1000 infants decreased from 717 to 713 (P=0.008) between period 1 and 2, with more outpatient and less inpatient blood draws in period 2. Between periods 1 and 2, total phototherapy decreased from 59 to 39 per 1000 infants (P<0.0001), with less inpatient and more readmission phototherapy. Universal TcB screening was implemented without increasing total blood draws or phototherapy treatment; however, it was associated with a shift in blood draws and phototherapy usage from inpatients to outpatients.

Reply to the correspondence letter: “Transcutaneous bilirubinometry: comparison of two devices in healthy term newborns”

Dear Editor, We would like to thank Teran C et al. for their comment on our article. We and Varvarigou et al. chose different transcutaneous bilirubinometers (JM-103 and BiliCheck, respectively), provided data on transcutaneous bilirubin (TcB) levels of neonates after birth and developed two different hour-specific TcB nomograms to predict significant hyperbilirubinemia [3, 4]. It is difficult for physicians to decide which device should be used to determine TcB levels, whereas the JM-103 (a two-wavelength measurement) and the BiliCheck (a multiwavelength measurement) are both approved by the U.S. Food and Drug Administration for estimating bilirubin concentrations in neonates. So, it is important to study simultaneous TcB by the two devices and total serum bilirubin (TSB) measurements from the same neonatal population in order to assess the different TcB nomograms for predicting significant hyperbilirubinemia. Carlos et al. have offered a novel perspective with a small study, which show that the two devices (JM-103 and BiliCheck) are both reliable, accurate and the measurements can be assessed on the basis of these nomograms with high accuracy to predict significant hyperbilirubinemia. Their results have further supplemented our study. Application of the two devices could both allow us for a noninvasive, risk-based approach for neonatal hyperbilirubinemia, but we should notice that TcB readings above 250 μmol/L should be interpreted with care because of the observed underestimation at high concentrations; all TcB values above the levels should be confirmed with a TSB measurement [2]. In addition, when we analyzed the sensitivity of TcB measurement to predict significant hyperbilirubinemia, we should consider the risk zone of TcB values in the hourspecific TcB nomogram. The TcB values in the different risk zone showed different detection sensitivity. In our study, when the TcB values by JM-103 were in high-risk zone (HRZ), intermediate-risk zone (IRZ), and low-risk zone (LRZ), the sensitivity was 26.9%, 78.7%, and 100%, separately. In the study by Dalal et al., when the TcB values by BiliCheck were in HRZ, IRZ, and LRZ, the sensitivity was 39.2%, 80.4%, and 98%, separately [1], which was consistent with our results. So, both devices (JM-103 and BiliCheck) are reliable, accurate, and suitable screening tools to identify jaundiced infants; in order to improve the detection sensitivity of TcB devices, we should combine the use of these devices with using the hour-specific TcB nomogram.

Clinical performance of the new glucometer in the nursery and neonatal intensive care unit

Performance of point-of-care (POC) glucometers in newborns have been unsatisfactory in low glucose concentration range and the effects of different hematocrit levels on glucose measurements have also demonstrated in currently used POC glucometers. The aim of this study was to evaluate the performance of the new glucometer (Nova-Statstrip(®) ; Nova Biomedical, Waltham, MA, USA) compared to the reference method. Venous blood specimens of neonates were collected and tested by the two glucometers. Standard reference was performed using the hexokinase method within 10 min of blood collection. Hematocrit and total serum bilirubin measurements were performed simultaneously. One hundred and fifty-one blood specimens were collected and measured by the reference method with plasma glucose concentrations ranging from 12 to 371 mg/dL. Twenty-one specimens had plasma glucose concentrations <45 mg/dL. At plasma glucose concentrations less than 75 mg/dL, the Statstrip(®) achieved 93% in the tests for discrepancy < 15 mg/dL. At a glucose concentration more than 75 mg/dL, 97% of the Statstrip(®) readings were within 20% of the reference values. The mean difference (±2SD) of the Statstrip(®) was 2.8 (-14.1, 19.7) mg/dL. At a hypoglycemic level (<45 mg/dL), it showed a sensitivity of 95.2%. No significant interference of hematocrit or total serum bilirubin was found on the mean bias of the Statstrip(®) . The new glucometer (Nova-Statstrip(®) ) could be used for point-of-care blood glucose measurement in neonates as it showed a narrow margin of error and had no hematocrit or bilirubin interference.

Comparison between transcutaneous bilirubinometry and total serum bilirubin measurements in preterm infants &lt;35 weeks gestation

Neonatal hyperbilirubinaemia is a common treatable cause of brain injury. The treatment for this condition is phototherapy. The decision whether to use phototherapy is currently dependent upon serum bilirubin assay results. However, repeated blood sampling is not only traumatic but may also be a cause of anaemia in neonates. We evaluated a transcutaneous bilirubin assay method to determine whether it was suitable for routine use in preterm infants. One hundred and eighty-three transcutaneous bilirubin measurements were taken contemporaneously with blood samples for laboratory measurement of serum bilirubin. The study was carried out with informed parental consent and approval by the local research ethics committee. The transcutaneous bilirubin method (BiliChek) exhibited a consistent positive bias compared with the laboratory bilirubin assay. Consequently, for a given detection rate, the transcutaneous method had a higher screen positive rate, i.e. more neonates would be given phototherapy if transcutaneous bilirubin results were used to decide. There was a margin of safety in the transcutaneous bilirubin assay calibration. The BiliChek transcutaneous bilirubin assay is a safe alternative to laboratory bilirubin assay in deciding whether to give preterm neonates phototherapy.

Bilirubin Screening for Normal Newborns: A Critique of the Hour-Specific Bilirubin Nomogram

Kernicterus is a devastating but rare disease with an incidence that ranges from 0.4 to 2.9 per 100000 live births.1–6 Recently, a preventive strategy of measuring predischarge bilirubin levels in all infants discharged from the newborn nursery was proposed and included as an option in the American Academy of Pediatrics guidelines.7 The percentile location of these levels on an hour-specific “nomogram” of total serum bilirubin (TSB) levels first described by Bhutani et al8 is thought to predict the risk of severe hyperbilirubinemia. In this commentary we highlight the methodologic flaws in the development of the nomogram, the lack of evidence for efficacy of screening, and the potential undesirable consequences of such an approach. Multiple flaws in the methods used to create the nomogram8 and assess its accuracy generate serious questions about its validity. Some of these issues were emphasized previously by experts on hyperbilirubinemia who stated that “the study biases and interlaboratory variability in TSB measurements preclude general extrapolation of the quantitative results of this study… ”9 First, the applicability of these percentile curves to the overall US or international population is suspect, because they were developed in a retrospective study that used a small sample of infants from a single urban Philadelphia, Pennsylvania, hospital, the demographics of which (43% white, 41% black, 4% Hispanic, and 4% … Address correspondence to David L. Fay, MD, Waukesha Family Medicine Residency Program, 210 NW Barstow, Suite 201, Waukesha, WI 53188. E-mail: david.fay{at}phci.org

Preventing kernicterus: a wake-up call

Preventing kernicterus: a wake-up call

A Comparison of Transcutaneous and Total Serum Bilirubin in Newborn Hispanic Infants at 35 or More Weeks of Gestation

Transcutaneous bilirubin (TcB) measurement in newborns has been studied extensively in the non-Hispanic population, but its usefulness in the Hispanic population remains unclear. We evaluate the accuracy of TcB measurements in assessing jaundice in Hispanic neonates by using total serum bilirubin (TSB) measurements as the reference standard and determine the TcB level that can be used to identify neonates at risk for clinically significant jaundice (above the 95th percentile). A total of 192 Hispanic neonates were enrolled. TcB measurements were performed within 30 minutes of obtaining the TSB measurement. The linear relationship between TcB and TSB was measured by using the Pearson correlation coefficient (r). We calculated sensitivity, specificity, and positive and negative predictive values by using a TcB level above the 75th percentile to identify neonates with a TSB level above the 95th percentile. TSB ranged from 1.7 to 13.9 mg/dL, with 62% falling below the 75th percentile. TcB correlated well with TSB in Hispanic neonates (r = 0.87). A TcB level above the 75th percentile detected all infants with a TSB level above the 95th percentile, sensitivity 100%, and specificity 66%. In Hispanic newborns, the TcB level correlated well with the TSB level. TcB monitoring is a useful clinical screening tool to evaluate for the risk of clinically significant jaundice.

Evaluation of a new transcutaneous bilirubinometer in Chinese newborns

Objective: To evaluate the use of a new transcutaneous bilirubinometer (JM-103 Minolta Airshields) for detection of hyperbilirubinaemia in term or near-term healthy Chinese newborns. Methods: Transcutaneous bilirubin (TcB) was used...

Transcutaneous bilirubinometry in neonates

In recent years, a new risk model for hyperbilirubinemia has emerged. There are several reasons for this. First, delivery of the health care system to the relatively healthy term or near-term infant and mother has changed, with earlier discharge and fewer routine tests (1). Second, physician awareness of the possibility of kernicterus in this population has changed, requiring increased vigilance (2). Third, the tendency toward demedicalization of the relatively healthy breastfed newborn has created the potential for development of severe hyperbilirubinemia (greater than 350 μmol/L). A recent study from Canada (2) concluded that severe hyperbilirubinemia continues to be observed in term and near-term neonates, with significant morbidity. Although jaundice occurs in the majority of newborns and most cases are benign, the newborn with severe jaundice must be identified, carefully followed and, if needed, treated appropriately because of the potential toxicity. Capillary collection of blood by heel puncture or blood collection from venous puncture has been the traditional method of screening and monitoring jaundice in neonates (3). This obviously causes pain and discomfort to infants and anxiety to parents. Transcutaneous bilirubin measurements using BiliChek (Respironics, USA) or other similar devices have been used sporadically in many countries, including the United States and Canada, for the screening of jaundiced infants. The clinical practice guideline that was recently published by the American Academy of Pediatrics (4) stated that there is an urgent need to improve the precision and accuracy of measurement of bilirubin in clinical laboratories. The Academy has called for additional studies on the cost-effectiveness and reproducibility of transcutaneous measurements of total serum bilirubin. Jaundice is first seen in the face of a newborn and generally progresses caudally to the body and the extremities. Visual estimation of jaundice will lead to errors; therefore, screening tools have been developed using noninvasive devices, such as BiliChek, to estimate bilirubin levels, and they have proven to be valid. Although studies are limited, they suggest a measurement within 34 μmol/L to 51 μmol/L when compared with serum bilirubin. A study by Jangaard et al (pages 79–83) evaluated the transcutaneous bilirubin device BiliChek by comparing transcutaneous bilirubin values with total serum bilirubin measurements in well term infants, ill term infants and preterm infants admitted to neonatal intensive care units, with and without phototherapy. The study consisted of two phases: in phase 1, 99 healthy, full-term infants who had not received phototherapy had transcutaneous bilirubin measurement performed simultaneously with heel puncture for serum bilirubin measurement. In phase 2, in 56 infants admitted to neonatal intensive care units, a total of 99 transcutaneous readings were performed at the time that serum bilirubin measurements were ordered for clinical reasons. The operators of the BiliChek device were blinded to the serum bilirubin levels. The authors found that transcutaneous bilirubin measurements were reasonably accurate for measuring bilirubin in term, jaundiced infants not undergoing phototherapy and in those receiving phototherapy if the area of skin was patched from the phototherapy. The BiliChek measurements were unreliable for preterm and ill infants. Jangaard et al should be congratulated for their work. Their study adds to the multiple other studies that are available comparing transcutaneous serum bilirubin measurements with capillary or venous bilirubin collection methods (5–7). Like others, they found that transcutaneous measurement has limitations. For instance, it becomes unreliable after initiation of phototherapy if the skin is not shielded from light because skin is bleached by the light. Their study did not address other important issues, such as varying degrees of skin thickness, skin colour and infants of different ethnic backgrounds, but the authors acknowledge these limitations. Future studies should include larger numbers of infants with larger numbers of measurements so that the reliability, specificity and sensitivity of such devices can be assessed. Infants in Canada are indeed from different ethnic backgrounds; therefore, variability, such as skin colour and thickness, becomes especially important in the Canadian population. Furthermore, it is crucial to investigate the cost-effectiveness of these instruments and the ability to use them for ongoing monitoring of jaundiced infants. If proven effective, these devices can be used to replace the traditional collection of serum from jaundiced infants for the measurement of bilirubin levels.

Evaluation of a point-of-care direct spectrophotometric method for measurement of total serum bilirubin in term and near-term neonates

To evaluate point-of-care (POC) measurement of total serum bilirubin (TSB) in the management of neonatal jaundice. TSB was measured by a POC direct spectrophotometric bilirubin method (Unistat (U/TSB)) and a standard diazo clinical laboratory method (Olympus AU640E analyzer (diazo/TSB)). Agreement between U/TSB and diazo/TSB was assessed by correlation coefficient and Bland-Altman analysis. Transcutaneous bilirubin (TcB) was measured using JM-103 (JM). Correlation between U/TSB and diazo/TSB was 0.99 (n = 120). Maximum difference (U/TSB minus diazo/TSB) was -2.9 mg/dl, and 79% were +/-1 mg/dl; the average difference was -0.37+/-0.70 mg/dl and the average absolute difference was 0.60+/-0.52 mg/dl. Median time to determine U/TSB was 5 min. Correlation between U/TSB and JM was 0.92 (n = 113). Maximum difference (U/TSB minus JM) was 6.3 mg/dl, and 45% were +/-1 mg/dl; the average difference was 0.7+/-1.8 mg/dl and the average absolute difference was 1.4+/-1.2 mg/dl. Measurement of TSB using Unistat provides excellent agreement with diazo/TSB and rapid turnaround time. This technique may provide reliable POC confirmation of TcB results that are above a screening cutoff value.

42 Protective Effects of Galacto- and Fructoolico-Saccharides on Neonatal Jaundice

Background: Neonatal hypebilirubinaemia occurs in approximately 8% to 20% of healthy, full-term newborn infants. Several mechanisms are implicated in pathogenesis of jaundice: decreased hepatic clearance, large hemoglobin mass degradation, and intestinal reabsorption. Reduction of bilirubin to urobilinoiods by the intestinal microbial flora may be enhanced by modification of intestinal microflora.Aim: To examine whether supplementing formula with oligosaccharide mixture may modulate bilirubin total (BT) levels in formula fed infants during the first weeks of life.Methods: Fifty healthy full-term infants born at the maternity ward of San Giovanni di Dio Hospital, Crotone, Italy, and formula fed from birth participated in the study. Written parental consent was obtained. Infants were double blind randomly allocated into two groups to receive either supplementation of oligosacharides mixture (galactooligosaccharides [gos-fos], derived from lactose, and long-chain fructooligosaccharides, derived from chicory) at the dosage of 0.8 g/100ml (n=27) or placebo (maltodexrine) (n=23), from birth through the first 28 days of life. BT level was determined by multiwavelength spectral analysis, using a portable BiliCheck device (SpectRx Inc, Norcross, GA), clinically equivalent to measurement of total serum bilirubin (transcutaneous bilirubin, TcB) within 2 hours after birth (T0), at 24, 48, 72 h and at completed 5, 7, 10, 28 (T8) days of life. Hematocrit (HT) was further determined by conventional methodsResults: Groups were comparable for birth weight, gestational age, maternal age, type of delivery, baseline (T0) plasma TcB level (mean [SD; range], gos-fos 3.0 [0.7; 2.1–4.8] vs. placebo 3.0 [0.8; 1.6–5.0] mg/dl, and HT level. Pattern of TcB significantly differed between groups through the study (P<0.01; Anova for repeated measures). Infants in supplemented group exhibited lower plasma TcB levels than placebo group from 72 h of life onwards (0.01<P<0.02). At T8, mean [SD; range] TcB level was 2.4 [0.5; 1.1–3.6] mg/dl (gos-fos) vs. 2.8 [0.4; 1.8–3.8] mg/dl (placebo). HT significantly decreased from birth to day 28 in both groups (P<0.0001) but no difference between groups was found (P>0.55).Conclusions: In formula fed infants, supplementation of a mixture of gos-fos significantly lowers bilirubin level after 72 hours of life. It may be hypothesize that stimulating the intestinal growth of bifidobacteria and lactobacilli enhances bilirubin excretion by reducing it to urobilinoids. Larger randomized trials would be of interest to evaluate prophylactic and therapeutic use of gos-fos in neonatal hyperbilirubinaemia.

Evaluation of a Transcutaneous Jaundice Meter Following Hospital Discharge in Term and Near-Term Neonates

To evaluate performance of the Minolta JM-103 Jaundice Meter (JM) as a predictor of total serum bilirubin (TSB) in outpatient neonates during the first week postnatal, and to estimate the number of TSB determinations that might be avoided in clinical use. In neonates evaluated posthospital discharge, JM and TSB results were compared using linear regression and a Bland-Altman plot, and predictive indices were calculated for various JM cutoff values. Utilizing the 2004 American Academy of Pediatrics (AAP) guidelines, the ability of JM to predict risk zone status was determined. Overall correlation between JM and TSB was 0.77 (p<0.001; n=121). When TSB was >17 mg/dl, a cutoff value for JM of 13 mg/dl had a sensitivity of 1.0, and 50% of TSB determinations would be avoided. JM may facilitate outpatient management of hyperbilirubinemia by reducing the number of TSB determinations required; however, it does not provide a reliable substitute for laboratory measurement of TSB.

Reduction in Hospital Readmission Rates for Hyperbilirubinemia Is Associated with Use of Transcutaneous Bilirubin Measurements

The use of transcutaneous bilirubin (TcB) measurements would seem to represent an opportunity to decrease the use of laboratory total serum bilirubin (TSB) testing because the former would serve as a surrogate for the latter. Many authors of previous studies have concluded that TcB measurements are useful and can serve as a reliable index for estimating TSB concentrations (1)(2)(3)(4), even in darkly pigmented neonates (5). Although the use of TcB measurements might represent, correspondingly, an opportunity to decrease expenses by decreasing laboratory TSB measurements, such a consequence would be dependent on several factors, including the cost of personnel and reagents for performing the TcB measurements and the number of TcB measurements performed. In addition, the TcB results might impact other caretaker practice behaviors, such as the ordering of TSB measurements and compliance with guidelines for the application of phototherapy, whether used in or outside the hospital, as governed by local practice routines. The newly revised American Academy of Pediatrics (AAP) Clinical Practice Guideline on management of hyperbilirubinemia in the newborn (6) would not necessarily affect or predict the interaction of these factors. In this issue of Clinical Chemistry , Petersen et al. (7) demonstrate that the introduction of TcB measurements for the identification of infants with hyperbilirubinemia was followed by a decrease in the number of hospital readmissions of infants with hyperbilirubinemia per 1000 births/month. However, they found that the interaction of various factors did not contribute to changes in the length of stay for normal newborns and that new costs, in addition to those for TcB measurements, arose from an increased use of laboratory TSB testing and increases in the number …

Transcutaneous bilirubinometry with the Bilicheck® in very premature newborns

Objectives: To investigate the potential advantages of use of the Bilicheck® in the very preterm population, with special emphasis on the effect of possible adverse skin conditions on the accuracy of the measurements. In addition we estimated the potential for safe reduction of the number of blood samples taken for serum bilirubin determinations by introduction of the Bilicheck® into the neonatal intensive-care unit (NICU). Methods: Total serum bilirubin (TSB) and transcutaneous bilirubin (TcB) were determined in very preterm newborns (gestational age < 30 weeks). To assess the agreement between TSB and TcB values, Bland-Altman plots were analyzed. Accuracy and (intra-device) imprecision were determined by statistical analysis. A screening model was developed to estimate the potential for safe reduction of the number of blood samples taken for TSB determination. Results: Correlations between TcB and TSB values varied between 0.86 and 0.88 and all were statistically significant. Bland-Altman plots and statistical analysis showed that the agreement between TcB and TSB measurements was largest for the group with good skin conditions, as expected. The Bilicheck® device had an acceptable level of intra-device imprecision (2.29 ± 13.51 μmol/l). Applying the screening model to our entire study population, 35 of the 93 TSB measurements (38%) could have been saved. Conclusions: The Bilicheck® is a screening device with the potential to reliably indicate hyperbilirubinemia in very preterm infants. Caution is required when skin measurements are performed in the presence of peripheral edema and/or a poor peripheral circulation. Its application in the NICU environment has the potential to reduce the number of blood samples by 40%.

Transcutaneous bilirubinometry with the Bilicheck® in very premature newborns

To investigate the potential advantages of use of the Bilicheck in the very preterm population, with special emphasis on the effect of possible adverse skin conditions on the accuracy of the measurements. In addition we estimated the potential for safe reduction of the number of blood samples taken for serum bilirubin determinations by introduction of the Bilicheck into the neonatal intensive-care unit (NICU). Total serum bilirubin (TSB) and transcutaneous bilirubin (TcB) were determined in very preterm newborns (gestational age < 30 weeks). To assess the agreement between TSB and TcB values, Bland-Altman plots were analyzed. Accuracy and (intra-device) imprecision were determined by statistical analysis. A screening model was developed to estimate the potential for safe reduction of the number of blood samples taken for TSB determination. Correlations between TcB and TSB values varied between 0.86 and 0.88 and all were statistically significant. Bland-Altman plots and statistical analysis showed that the agreement between TcB and TSB measurements was largest for the group with good skin conditions, as expected. The Bilicheck device had an acceptable level of intra-device imprecision (2.29 +/- 13.51 micromol/l). Applying the screening model to our entire study population, 35 of the 93 TSB measurements (38%) could have been saved. The Bilicheck is a screening device with the potential to reliably indicate hyperbilirubinemia in very preterm infants. Caution is required when skin measurements are performed in the presence of peripheral edema and/or a poor peripheral circulation. Its application in the NICU environment has the potential to reduce the number of blood samples by 40%.

Assessment of neonatal hyperbilirubinemia using a transcutaneous bilirubinometry

The purpose of the study is to investigate the relationship between total serum bilirubin(TSB) and transcutaneous bilirubinometry(TcB) in neonates with jaundice. TcB from various sites(forehead, sternum, abdomen, buttock, hand, dorsalis-pedia) was measured using a JM-102 in a total of 102 neonate, 42 female and 60 male, with the mean 37.5 gestational week and the mean 2,903 gram of birth weight, as well as TSB from capillary punctures. The mean bilirubin was 11.73 in serum, 20.55 on the forehead, 17.23 on the sternum, 16.19 on the abdomen, 18.22 on the buttock, 15.83 on the hand and 15.49 on the dorsalis-pedia. The relationship between TSB and TcBs were formulated by simple regression with 0.406 < r < 0.668(p <.000). A higher relationship was revealed between TSB and TCB at the forehead in infants of full-term, ABO incompatibility, and Hb greater than 16 mg/dl(r = 0.725, 0.790, and 0.717, retrospectively). Phototherapy altered the measurement of TcB per site. TcB on the forehead is a reliable, noninvasive and convenient measurement of TSB in normal infants(Institutions need to establish quantitative equations representing the specific relationship between TSB and TCB according to the hemodynamic problems of infants such as ABO incompatibility, or low Hb).

Transcutaneous bilirubin measurement: a multicenter evaluation of a new device.

The early discharge of neonates from hospitals makes transcutaneous measurement of total bilirubin concentration a useful tool to monitor neonatal jaundice. The objectives of this study were to determine whether 1) transcutaneous bilirubin (TcB) measurement, as performed using BiliCheck (BC), correlates with total serum bilirubin (TSB) levels, measured with standard laboratory methods and with high-pressure liquid chromatography (HPLC-B); 2) infant race, gestational age, postnatal age, or body weight interferes with the measurement of TcB levels in newborn infants; 3) the variability of the TcB measurement is comparable to the variability of TSB measurements; and 4) TcB measurements obtained from the forehead (BCF) and sternum (BCS) generate comparable results. Newborn infants who were <28 days and >30 weeks' gestational age and who underwent tests for TSB as part of their normal care in 6 different European hospitals were studied. A total of 210 infants were enrolled in the study, 35 at each site. Near simultaneous (within +/- 30 minutes) blood collection for TSB and BCF and BCS measurements were performed. TSB levels were determined by the serum bilirubin method in use at each site, and all HPLC-B determinations were made at the same, independent laboratory. The study group consisted of 140 white, 31 Asian, 14 Hispanic, 9 African, and another 16 newborns of different races. The correlation coefficient (r) between BCF and HPLC-B was 0.890 (95% confidence interval = 0.858-0.915). BCF and BCS generated similar results (r value = 0.890 for BCF and 0.881 for BCS), even if BCS slightly overestimated (mean error = -0.04 mg/dL) and BCF slightly underestimated (mean error = 0.96 mg/dL) in comparison with HPLC-B. Analysis of covariance demonstrated that BC accuracy was independent of race, birth weight, gestational age, and postnatal age of the newborn. Receiver operating characteristic curves were evaluated for BCF and TSB, each compared with HPLC-B. With the use of a cutoff point for HPLC-B of 13 mg/dL (222 micromol/L) and a cutoff of 11 mg/dL on the BCF and TSB, similar sensitivity/specificity (93%/73% for BCF, 95%/76% for TSB) were observed. The use of a cutoff point for HPLC-B of 17 mg/dL (290 micromol/L) and 14 mg/dL (240 micromol/L) for BCF and TSB also produced similar sensitivity/specificity (90%/87% for the BC and 87%/83% for TSB). Because the correlation coefficient for HPLC-B and BCF is very similar to that found for HPLC-B and laboratory TSB, BC could be used not only as a screening device but also as a reliable substitute of TSB determination. At higher levels of TSB, in which phototherapy and/or exchange transfusion might be considered, BC performed slightly better than the laboratory. The accuracy and precision of the TcB measurement in this study was observed to be comparable to the standard of care laboratory test.

Non-Invasive Measurement of Total Serum Bilirubin by Multi-Wavelength Spectral Reflectance by Bili Check (TM) in Newborn Patients † 968

Non-Invasive Measurement of Total Serum Bilirubin by Multi-Wavelength Spectral Reflectance by Bili Check (TM) in Newborn Patients † 968